New combination treatment for diabetes supports a more personalized approach to disease management

the ONA take:

Diabetes is estimated to affect 29.1 million people in the United States, and its prevalence is projected to reach more than 592 million people worldwide by 2035.

Xigduo XR, a new once-daily treatment for adults with type 2 diabetes, was recently by the US FDA. Xigduo XR combines two antihyperglycemic agents with complementary mechanisms of action in a once-daily oral tablet: dapagliflozin (Farxiga), an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride extended-release, a biguanide.

This medication is contraindicated in patients with moderate to severe renal impairment; a history of a serious hypersensitivity to dapagliflozin or to metformin HCl; or with metabolic acidosis, including diabetic ketoacidosis. Contraindications that may impact care of oncology patients include surgical procedures—it should be suspended for any surgical procedure associated with restricted intake of food and fluids, and not restarted until patient’s oral intake has resumed and renal function is normal or mildly impaired—and radiologic studies with intravascular iodinated contrast materials.

In addition, across 22 clinical studies, newly diagnosed cases of bladder cancer were reported in 0.17% of patients treated with dapagliflozin and 0.03% in patients treated with placebo/comparator. Bladder cancer risk factors and hematuria were balanced between the treatment arms at baseline. However, too few cases occurred to determine whether the emergence of these events was related to dapagliflozin.

Type 2 diabetes is a chronic disease characterized by pathophysiologic defects leading to elevated glucose levels. Elderly patients and patients with impaired renal function may be more susceptible to increased serum creatinine and decreased eGFR as a result of treatment with dapagliflozin.

AstraZeneca today announced that the U.S. Food and Drug Administration has approved once-daily XIGDUO™ XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes.

XIGDUO XR combines two anti-hyperglycemic agents with complementary mechanisms of action, dapagliflozin (trade name in the U.S. FARXIGA™), an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride (HCl) extended-release, a biguanide, in a once-daily oral tablet. SGLT2 inhibitors are a relatively new class of medicines that remove glucose from the body via the kidneys.